NCT03274206Unknown2 期
A Phase 2b Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)
BioLeaders Corporation14 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2017年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 126
- 试验地点
- 14
- 主要终点
- Regression rate
研究概览
简要总结
This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will receive the experimental drug, while 1/3 of participants will receive placebo.
详细描述
Primary Outcome Measure:
Complete histopathological regression from baseline [Time Frame: Baseline through Week 16]
Secondary Outcome Measures:
- Change from baseline of CIN classification [Time Frame: Baseline through Week 16]
- Change from baseline of RCI [Time Frame: Baseline through Week 16 and Week 32]
- Change from baseline of cytopathological classification based on bethesda system [Time Frame: Baseline through Week 16 and Week 32]
- Change from baseline as compared to placebo in the expression rate of P16/Ki-67 [Time Frame: Baseline through Week 16]
- Change from baseline as compared to placebo of the number of CD8 positive cells in the cervical tissue [Time Frame: Baseline through Week 16]
- Change from baseline as compared to placebo in HPV 16 clearance rate
- Change of RCI based on the histopathological regression at Week 16 [Time Frame: Week 16 through Week 32]
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Fertile female aged between 20 and 49
- •Subjects who are infected with HPV 16 type only or with HPV 16 type and any other types listed below
- •low risk type of HPV, 2) HPV 16-related type
- •Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by colposcopic biopsy within 6 weeks before enrollment
- •All lesions must be observable by colposcopy and CIN2 or higher lesion must be less than 1/2 in the transformation zone area
- •Willing to use adequate contraception methods during the study period
- •Eligible based on screening test results
- •Normal electrocardiogram
- •Voluntarily signed informed consent form
排除标准
- •Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious invation
- •Presence of adenocarcinoma or glandular lesion in the cervix
- •Subjects who are infected with HPV type 18-related type
- •Subjects with autoimmune disease
- •Current or prior treatment past 2 months with immunosuppressant therapies
- •Hypersensitive to the investigational drug
- •Subjects who currently have acute diseases that require medical attention
- •Participation in other studies involving investigational drug(s) or investigational device(s) within 3 months
- •Currently having chronic pancreatitis or diagnosed with acute pancreatitis
- •Currently having underlying diseases including inflammatory intestinal diseases and tumors, ulcer, bleeding or puncture in the gastrointestinal tract
- •Pregnant or breastfeeding
- •Subjects with active or inactive hepatitis, or infectious disease
- •History of HIV infection
- •History of therapeutic HPV vaccination
- •Subjects who require continuous use of antibiotics
- •Administration of blood product within 3 months before signing informed consent form
- •History of vaccination within 2 months before signing informed consent form (4 months in case of live vaccine)
研究组 & 干预措施
BLS-ILB-E710c
Experimental
- Drug: BLS-ILB-E710c 1,000mg
- Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
干预措施: BLS-ILB-E710c (Biological)
BLS-ILB-E710c-placebo
Placebo Comparator
- Drug: BLS-ILB-E710c-placebo
- Dosage and duration: 4 capsules per day for 5 consecutive days at week 1,2,4, and 8)
干预措施: Placebo (Drug)
结局指标
主要结局
Regression rate
时间窗: Baseline through Week 16
The rate of complete histopathological regression from baseline as compared to placebo
次要结局
- Change of Reid's Colposcopic Index (RCI)(Baseline through Week 16 and Week 32)
- Cytopathological classification(Baseline through Week 16 and Week 32)
- Expression rate of P16/Ki-67(Baseline through Week 16)
- The number of CD8 positive cells in the cervix(Baseline through Week 16)
- CIN classification(Baseline through Week 16)
- HPV 16 clearance rate(Baseline through Week 16)
- Change of RCI(Week 16 and Week 32)
研究者
研究点 (14)
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